Methods | Method of randomization: stochastic treatment allocation algorithm based on the variance method Method of allocation concealment: centralized randomization where the study co‐ordinator was instructed the code of the medication for the patient after determining her eligibility. The medication packet was not opened until just before administering the injection Masking: Participants: yes Care providers: examiner: yes; injector: no Outcome assessors: yes Number randomized: 151 to 0.3 mg pegaptanib, 155 to 1 mg pegaptanib, 153 to 3 mg pegaptanib, and 153 to placebo Exclusions after randomization: none Number analyzed: 151 in 0.3 mg pegaptanib group, 155 in 1 mg pegaptanib group, 153 in 3 mg pegaptanib group, and 153 in placebo group for the primary outcome alone Losses to follow‐up: 12 in placebo group, 11 in 0.3 mg pegaptanib group, 13 in 1 mg pegaptanib group, and 17 in 3 mg pegaptanib group discontinued therapy during the trial Intention‐to‐treat analysis: yes; except don't know why 18 patients were excluded after randomization Unit of analysis: individuals Reported power calculations: yes |
Participants | Country: USA, Canada, Europe, Israel, Australia, South America Age: mean age was 74.9, 74.5, 75.4, and 74.9 years in 0.3 mg pegaptanib, 1 mg pegaptanib, 3 mg pegaptanib, and placebo groups, respectively Gender: 54%, 56%, 61%, and 63% in 0.3 mg pegaptanib, 1 mg pegaptanib, 3 mg pegaptanib, and placebo groups, respectively, were female Inclusion criteria: age greater than or equal to 50 years; subfoveal choroidal neovascularization (CNV) secondary to age‐related macular degeneration; best‐corrected visual acuity of 20/40 to 20/320 in the treated eye and greater than 20/800 in the fellow eye; CNV lesion may be predominantly classic, minimally classic, occult with no classic; size of lesion < 12 disc areas (including blood, scar/atrophy, neovascularization); no greater than 50% of lesion could be due to subretinal hemorrhage and 50% of lesion had to be due to CNV; for occult lesions, lesions had to be subretinal and no greater than 50% of total lesion area, or presence of lipid or loss of 15 letters or more of visual acuity during previous 12 weeks; patients were eligible even if they received 1 photodynamic treatment if it was at least 8 to 12 weeks before enrollment; intraocular pressure < 23 mmHg; adequate pupil dilation; clear media Exclusion criteria: atrophy exceeding 20% of total lesion or subfoveal scarring; previous thermal laser; therapy with another investigational drug; likelihood of requiring cataract removal within 2 years; other potential causes of CNV including high myopia, ocular histoplasmosis, angioid streaks, choroidal rupture, multifocal choroiditis, any intraocular surgery within 3 months or extrafoveal/juxtafoveal laser within 2 weeks of study entry, or posterior vitrectomy or scleral buckle or presence of intraretinal tears or rips; concomitant presence of diabetic retinopathy, severe cardiac disease, myocardial infarction within 6 months, ventricular tachycardia requiring treatment, unstable angina, evidence of peripheral vascular disease, stroke within 12 months, acute or chronic periocular infection, previous therapeutic radiation to eye/head/neck; any treatment with any investigational agent within last 30 days; serious allergies to fluorescein dye or indocyanine green or components of pegaptanib Equivalence of baseline characteristics: treatment groups were similar with respect to age, gender, race, smoking status, angiographic subtypes, prior treatment status with photodynamic therapy, and Early Treatment Diabetic Retinopathy Study visual acuity scores |
Interventions | Treatment: intravitreal injection of pegaptanib at dosages of 0.3 mg, 1.0 mg, or 3.0 mg given every 6 weeks over period of 48 weeks Control: sham injection with participants treated identically with the exception of scleral penetration with the needle Length of follow‐up: 54 weeks |
Outcomes | Primary outcome: proportion of participants losing fewer than 15 letters of visual acuity between baseline and week 54 Other outcomes reported: gain of 3 or more lines of visual acuity, maintenance of visual acuity or gain of 0 lines of visual acuity, mean visual acuity, legal blindness, loss of 30 letters or more of visual acuity, size of lesion, and total CNV size Reported quality of life indicators: yes Intervals at which outcome assessed: every 6 weeks before treatment, with main assessment analyzed after 54 weeks |
Notes | Funding: Eyetech Pharmaceuticals and Pfizer NCT00021736 |